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Abstract:

Apparatus enables one or more needleless injection ports to be
established on IV tubing as needed. An IV tubing-engaging portion secures
the apparatus about the tubing. A puncturing member establishes fluid
communication between the IV line and a sealing member on the apparatus.
Connecting a syringe to the sealing member establishes fluid
communication between the IV line and the syringe, enabling an injection
to be made. When the syringe is withdrawn, the sealing member reseals to
prevent fluid leakage from the IV line.

Claims:

1. Apparatus configured to be secured to intravenous (IV) tubing to
establish a needleless injection/aspiration port on the IV tubing, the
apparatus comprising: an IV tubing-engaging portion having an internal
surface defining an internal bore configured to wrap around an external
surface of the IV tubing; a branch portion extending from the IV
tubing-engaging portion. the branch portion including a lumen; a valve
member comprising a body section having an inlet coupled to the branch
portion, said valve member comprising a compressible piston having a
hollow interior cavity disposed, at least in part, inside the body
section for regulating fluid flow through the inlet of the body section:
wherein a piercing member having a shaft and a sharp tip is disposed, at
least in part, inside the hollow interior cavity of the compressible
piston; and wherein the piercing member is structured to move axially
from a first position inside the hollow interior cavity of the
compressible piston to a second position in which at least part of the
piercing member is moved inside the internal bore of the IV
tubing-engaging portion.

2. Apparatus configured to be secured to intravenous (IV) tubing to
establish a needleless injection/aspiration port on the IV tubing, the
apparatus comprising: an IV tubing-engaging portion having an internal
surface configured to snugly engage an external surface of the IV tubing;
a tubular branch portion extending from the IV tubing-engaging portion,
the branch portion including a lumen; a first elastomeric sealing member
located at a junction of the IV tubing-engaging portion and the branch
portion, the sealing member fluidly isolating the lumen of the branch
portion from an interior of the IV tubing-engaging portion; a piston
portion engaging the branch portion, a central shaft of the piston
portion disposed at least partially within the lumen of the branch
portion, the central shaft including a lumen; a puncturing member
extending distally from the central shaft and including a lumen and a
pointed distal tip; and a valve member engaging a proximal end of the
piston portion, the valve member including a second elastomeric sealing
member that provides selective sealing of a proximal end of the piston
portion; wherein relative translation of the piston portion with respect
to the branch portion in a first direction drives the pointed tip of the
puncturing member through the first elastomeric sealing member and
through a sidewall of the IV tubing to establish fluid communication
between an interior of the IV tubing and the lumen in the puncturing
member.

3. The apparatus of claim 2, wherein a proximal end of the branch portion
includes at least one external thread, and an internal threaded surface
of the piston portion engages the at least one external thread on the
branch portion.

4. The apparatus of claim 2, wherein the second elastomeric sealing
member includes a slit configured to receive a male portion of an
injection apparatus to establish fluid communication between the interior
of the IV tubing and the injection apparatus.

5. The apparatus of claim 4, wherein a proximal end of the valve member
includes a female Luer fitting configured to engage the injection
apparatus.

6. The apparatus of claim 2, wherein the IV tubing-engaging portion
includes first and second sections hinged to one another, the first and
second sections including an open configuration in which the first and
second sections are freely pivotable with respect to one another and a
closed configuration in which the first and second sections at least
partially surround a portion of the IV tubing.

7. The apparatus of claim 6, wherein the hinged portions include a
latching mechanism that secures the first and second sections in the
closed configuration to resist removal of the apparatus from the IV
tubing.

8. The apparatus of claim 2, further comprising a stabilizer extending
proximally from an exterior surface of the IV tubing-engaging portion,
the stabilizer engaging an exterior of the piston portion to support the
piston portion during rotation relative to the branch portion.

9. The apparatus of claim 8, wherein the stabilizer comprises first and
second uprights located on opposite sides of the piston portion.

10. The apparatus of claim 8. wherein the stabilizer and the piston
portion include overlapping flanges that resist axial movement of the
piston portion proximally with respect to the stabilizer.

11. The apparatus of claim 2, wherein the IV tubing-engaging portion
further comprises a clamp configured to pinch the IV tubing to restrict
fluid flow therethrough.

12. A method of securing apparatus to intravenous (IV) tubing to create a
needleless injection/aspiration port on the IV tubing, the method
comprising: positioning a first section of an IV tubing-engaging portion
of the apparatus on the IV tubing; moving a second section of the IV
tubing-engaging portion relative to the first section to at least
partially surround a length of the IV tubing and to bring an internal
surface of the IV tubing-engaging portion into snug engagement with an
external surface of the IV tubing; engaging an injection apparatus with a
valve member of the apparatus such that a male portion of the injection
apparatus penetrates a slit in a first elastomeric sealing member of the
valve member to open fluid communication through the valve member;
translating the valve member and a piston portion to which the valve
member is secured in a first direction relative to a tubular branch
portion extending perpendicularly to the IV tubing-engaging portion;
advancing the piston portion toward the IV tubing as the piston portion
translates relative to the branch portion; advancing a puncturing member
that extends distally from the piston portion toward the IV tubing as the
piston portion advances toward the IV tubing; puncturing a second
elastomeric sealing member located at a junction of the IV
tubing-engaging portion and the branch portion with the puncturing member
as it advances toward the IV tubing; and puncturing the IV tubing with
the puncturing member to establish fluid communication between an
interior of the IV tubing and a lumen in the puncturing member.

13. The method of claim 12, wherein bringing the internal surface of the
IV tubing- engaging portion into snug engagement with the external
surface of the IV tubing establishes a seal at an interface between the
internal surface and the IV tubing.

14. The method of claim 12, wherein engaging the injection apparatus with
the valve member includes engaging a first Luer fitting on the injection
apparatus with a second Luer fitting on the valve member and rotating the
injection apparatus relative to the valve member.

15. The method of claim 12, wherein advancing the piston portion toward
the IV tubing comprises advancing a central shaft of the piston portion
into a lumen of the branch portion.

16. The method of claim 12, wherein as the puncturing member advances
through the second elastomeric sealing member the second elastomeric
sealing member creates a seal at an interface between the puncturing
member and the second elastomeric sealing member.

17. The method of claim 12, further comprising latching the first and
second sections of the IV tubing-engaging portion to one another to
resist removal of the apparatus from the IV tubing.

18. The method of claim 12, further comprising clamping the IV tubing to
restrict fluid flow therethrough from a point upstream of the puncturing
member.

19. The method of claim 12, further comprising injecting a fluid from the
injection apparatus through the valve member and into the IV tubing.

20. The method of claim 12, further comprising disengaging the injection
apparatus from the valve member to reestablish a seal at the slit in the
first elastomeric sealing member.

21. A method for forming a port for use with IV tubing, the method
comprising: forming a saddle comprising a bore sized to accommodate an IV
tubing; extending a branch from the saddle, said branch extending at an
angle to the saddle and comprises a cavity; locating a shaft inside the
cavity; said shaft being movable inside the cavity and comprises a lumen;
locating a puncturing device coaxially with the shaft; said puncturing
device comprises a lumen and a sharp tip; and coupling a needleless
access valve comprising a piston, a sealable inlet, and a fluid channel,
directly or indirectly, to the shaft so that the fluid channel is in
fluid communication with the lumen of the puncturing device.

22. Apparatus configured to be secured to intravenous (IV) tubing to
establish a needleless injection/aspiration port on the IV tubing, the
apparatus comprising: an IV tubing-engaging portion comprising a seam and
a bore sized to wrap around an IV tubing; a needleless access port valve
coupled to the IV tubing-engaging portion; said valve comprising a valve
body having an inlet, a fluid channel, and a compressible piston for
controlling fluid flow through the inlet disposed inside an interior
cavity of the valve body; a piercing assembly comprising a holding member
attached to a piercing member comprising a sharp tip and a lumen in fluid
communication with the fluid channel of the valve body; and wherein the
holding member and the piercing member are movable when at least one of
the valve body and the compressible piston is moved relative to the IV
tubing-engaging portion.

23. Apparatus configured to be secured to intravenous (IV) tubing to
establish a needleless injection/aspiration port on the IV tubing, the
apparatus comprising: an IV tubing-engaging portion configured to extend
around the IV tubing; a branch portion extending from the IV
tubing-engaging portion, the branch portion including a lumen; and a
piercing member having a shaft and a sharp tip, the piercing member being
disposed, at least in part, within the branch portion lumen; wherein the
piercing member is structured to move from a first position within the
branch portion lumen to a second position in which at least part of the
piercing member is moved inside the IV tubing-engaging portion.

24. The apparatus of claim 23, further comprising a valve member
comprising a body section having an inlet coupled to the branch portion.
said valve member comprising a compressible piston having a hollow
interior cavity disposed, at least in part inside the body section for
regulating fluid flow through the inlet of the body section.

25. The apparatus of claim 24, wherein the piercing member is disposed,
at least in part, within the hollow interior cavity of the compressible
piston when in the first position.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a national phase application of International
Application No. PCT/US2010/042196, filed Jul. 15, 2010, which claims the
benefit of U.S. Provisional Application No. 61/226,204, filed Jul. 16,
2009, the contents of which are expressly incorporated herein by
reference.

BACKGROUND

[0002] The embodiments discussed herein relate to needleless ports for
injecting fluids into an IV line.

DESCRIPTION OF RELATED ART

[0003] When a patient is receiving intravenous (IV) fluids. it is
sometimes necessary to also give the patient an injection of medicine.
Since the patient already has an IV line connected, it is advantageous to
give the injection through the IV line to avoid having to stick another
needle into the patient. Several products on the market enable injections
to be administered into the IV line so that the injected fluid can flow
into the patient through the IV line. Such products provide a needleless
injection port at a convenient point along the length of the IV line.

[0004] Unfortunately, known needleless injection ports are permanently
integrated into IV tubing. They thus raise the cost of producing the
tubing. The extra cost may be wasted if the port is ultimately never
used.

SUMMARY

[0005] The various embodiments of the present apparatus for selectively
establishing a needleless injection port on IV tubing, and associated
methods, have several features, no single one of which is solely
responsible for their desirable attributes. Without limiting the scope of
the present embodiments as expressed by the claims that follow, their
more prominent features now will be discussed briefly. After considering
this discussion, and particularly after reading the section entitled
"Detailed Description of the Preferred Embodiments," one will understand
how the features of the present embodiments provide advantages, which
include the capability to selectively establish one or more needleless
injection ports at any point along an IV tube whenever desired.

[0006] One aspect of the present apparatus and methods includes the
realization that existing products sometimes unnecessarily increase the
cost of producing IV tubing. When an IV tube including a permanently
integrated needleless injection port is used. the cost of using that IV
tube is greater than the cost of using an IV tube that does not include a
needleless injection port. If the port is never used. the extra cost is
wasted. It would be advantageous to have the capability to selectively
establish one or more needleless injection ports as desired, so that IV
tubing can be produced without the added expense of integrating permanent
needleless injection ports. Needleless injection ports would then seldom
be wasted, because they could be established only when needed.

[0007] One embodiment of the present apparatus is configured to be secured
to intravenous (IV) tubing to establish a needleless injection/aspiration
port on the IV tubing. The apparatus comprises an IV tubing-engaging
portion having an internal surface defining an internal bore configured
to wrap around an external surface of the IV tubing. The apparatus
further comprises a branch portion extending from the IV tubing-engaging
portion. The branch portion includes a lumen. The apparatus further
comprises a valve member comprising a body section having an inlet
coupled to the branch portion. The valve member comprises a compressible
piston having a hollow interior cavity disposed, at least in part, inside
the body section for regulating fluid flow through the inlet of the body
section. A puncturing member having a shaft and a sharp tip is disposed,
at least in part, inside the hollow interior cavity of the compressible
piston. The puncturing member is structured to move axially from a first
position inside the hollow interior cavity of the compressible piston to
a second position in which at least part of the puncturing member is
moved inside the internal bore of the IV tubing-engaging portion.

[0008] Another embodiment of the present apparatus is configured to be
secured to intravenous (IV) tubing to establish a needleless
injection/aspiration port on the IV tubing. The apparatus comprises an IV
tubing-engaging portion having an internal surface configured to snugly
engage an external surface of the IV tubing. The apparatus further
comprises a tubular branch portion extending from the IV tubing-engaging
portion. The branch portion includes a lumen. The apparatus further
comprises a first elastomeric sealing member located at a junction of the
IV tubing-engaging portion and the branch portion. The sealing member
fluidly isolates the lumen of the branch portion from an interior of the
IV tubing-engaging portion. The apparatus further comprises a piston
portion engaging the branch portion. A central shaft of the piston
portion is disposed at least partially within the lumen of the branch
portion. The central shaft includes a lumen. The apparatus further
comprises a puncturing member extending distally from the central shaft
and including a lumen and a pointed distal tip. The apparatus further
comprises a valve member engaging a proximal end of the piston portion.
The valve member includes a second elastomeric sealing member that
provides selective sealing of a proximal end of the piston portion.
Relative translation of the piston portion with respect to the branch
portion in a first direction drives the pointed tip of the puncturing
member through the first elastomeric sealing member and through a
sidewall of the IV tubing to establish fluid communication between an
interior of the IV tubing and the lumen in the puncturing member.

[0009] One embodiment of the present methods of securing apparatus to
intravenous (IV) tubing to create a needleless injection/aspiration port
on the IV tubing comprises positioning a first section of an IV
tubing-engaging portion of the apparatus on the IV tubing. The method
further comprises moving a second section of the IV tubing-engaging
portion relative to the first section to at least partially surround a
length of the IV tubing and to bring an internal surface of the IV
tubing-engaging portion into snug engagement with an external surface of
the IV tubing. The method further comprises engaging an injection
apparatus with a valve member of the apparatus such that a male portion
of the injection apparatus penetrates a slit in a first elastomeric
sealing member of the valve member to open fluid communication through
the valve member. The method further comprises translating the valve
member and a piston portion to which the valve member is secured in a
first direction relative to a tubular branch portion extending
perpendicularly to the IV tubing-engaging portion. The method further
comprises advancing the piston portion toward the IV tubing as the piston
portion translates relative to the branch portion. The method further
comprises advancing a puncturing member that extends distally from the
piston portion toward the IV tubing as the piston portion advances toward
the IV tubing. The method further comprises puncturing a second
elastomeric sealing member located at a junction of the IV
tubing-engaging portion and the branch portion with the puncturing member
as it advances toward the IV tubing. The method further comprises
puncturing the IV tubing with the puncturing member to establish fluid
communication between an interior of the IV tubing and a lumen in the
puncturing member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The various embodiments of the present apparatus for selectively
establishing a needleless injection port on IV tubing, and associated
methods. now will be discussed in detail with an emphasis on highlighting
the advantageous features. These embodiments depict the novel and
non-obvious apparatus shown in the accompanying drawings. which are for
illustrative purposes only. These drawings include the following figures,
in which like numerals indicate like parts:

[0011]FIG. 1A is a front perspective view of one embodiment of the
present apparatus for selectively establishing a needleless injection
port on an IV tubing;

[0012]FIG. 1B is a front cross-sectional view of the apparatus of FIG.
1A. illustrating the apparatus secured to the IV tubing;

[0013]FIG. 1 is a front perspective view, of another embodiment of the
present apparatus for selectively establishing a needleless injection
port on IV tubing, illustrating the apparatus secured to IV tubing with
an injection apparatus exploded from the injection port;

[0014]FIG. 2 is a bottom. right-side perspective view of another
embodiment of the present apparatus for selectively establishing a
needleless injection port on IV tubing, illustrating the apparatus
engaging IV tubing;

[0015] FIGS. 3 and 3A are a front cross-sectional view of the apparatus of
FIG. 2 taken through the line 3-3 in FIG. 2;

[0016]FIG. 4 is a right-side cross-sectional view of another embodiment
of the present apparatus for selectively establishing a needleless
injection port on IV tubing. illustrating the apparatus engaging IV
tubing;

[0017]FIG. 5 is a right-side cross-sectional view of the apparatus of
FIG. 4. illustrating a puncturing member of the apparatus penetrating the
IV tubing;

[0018]FIG. 6 is a right-side cross-sectional view of another embodiment
of the present apparatus for selectively establishing a needleless
injection port on IV tubing, illustrating the apparatus engaging IV
tubing;

[0019]FIG. 7 is a right-side cross-sectional view of the apparatus of
FIG. 6, illustrating a puncturing member of the apparatus penetrating the
IV tubing:

[0020]FIG. 8 is a right-side cross-sectional view of another embodiment
of the present apparatus for selectively establishing a needleless
injection port on IV tubing. illustrating the apparatus engaging IV
tubing;

[0021]FIG. 9 is a right-side cross-sectional view of the apparatus of
FIG. 8. illustrating a puncturing member of the apparatus penetrating the
IV tubing;

[0022]FIG. 10 is a right-side cross-sectional view of another embodiment
of the present apparatus for selectively establishing a needleless
injection port on IV tubing, illustrating the apparatus engaging IV
tubing;

[0023]FIG. 10A is a detail view of the portion of FIG. 10 indicated by
the box labeled 10A;

[0024]FIG. 10B is a detail view of one embodiment of the portion of FIG.
10 indicated by the box labeled 10B/10C;

[0025]FIG. 10c is a detail view of another embodiment of the portion of
FIG. 10 indicated by the box labeled 10B/10C:

[0026]FIG. 11 is a right-side cross-sectional view of the apparatus of
FIG. 10, illustrating a puncturing member of the apparatus penetrating
the IV tubing;

[0027] FIG. 12 is a front cross-sectional view of the apparatus of FIG. 11
taken through the line 12-12 in FIG. 11;

[0028]FIG. 12A is an alternative front cross-sectional view of the
apparatus of FIG. 11 taken through the line 12-12 in FIG. 11;

[0029]FIG. 13 is a rear perspective view of another embodiment of the
present apparatus for selectively establishing a needleless injection
port on IV tubing, illustrating the apparatus engaging IV tubing;

[0030]FIG. 14 is a rear cross-sectional view of the apparatus of FIG. 13
taken through the line 14-14 in FIG. 13;

[0031]FIG. 15 is a front perspective view of another embodiment of the
present apparatus for selectively establishing a needleless injection
port on an IV tubing;

[0032]FIG. 16 is a front elevation view of a piston portion configured
for use with the apparatus of FIG. 15;

[0033]FIG. 17 is a front perspective view of the apparatus of FIG. 15 in
combination with the piston portion of FIG. 16;

[0034]FIG. 18 is a front perspective view of another embodiment of the
present apparatus for selectively establishing a needleless injection
port on an IV tubing;

[0035]FIG. 19 is a lower perspective view of the piston portion of the
apparatus of FIG. 18;

[0036]FIG. 20 is a front perspective view of a portion of another
embodiment of the present apparatus for selectively establishing a
needleless injection port on an IV tubing; and

[0037]FIG. 21 is a front perspective view of a piston portion configured
for use with the portion of FIG. 20.

DETAILED DESCRIPTION

[0038] The following detailed description describes the present
embodiments with reference to the drawings. In the drawings, reference
numbers label elements of the present embodiments. These reference
numbers are reproduced below in connection with the discussion of the
corresponding drawing features.

[0039] As used herein, the term "proximal" describes a surface or portion
of a component that is located nearer to the operator than other surfaces
or portions of that component when the apparatus is in use. Similarly,
the term "distal" describes a surface or portion of a component that is
located farther from the operator than other surfaces or portions of that
component when the apparatus is in use.

[0040] FIGS. 1A and 1B illustrate one embodiment of the present apparatus
700 for selectively establishing a needleless injection port on
intravenous (IV) tubing 34. The apparatus 700 includes an IV
tubing-engaging portion or saddle 702 configured to at least partially
surround a portion of the IV tubing 34 to secure the apparatus 700 to the
tubing 34. The tubing 34 is, or can be, connected to an IV supply source,
such as a diluent or IV solution. and/or to a patient. With reference to
FIG. 1A, the IV tubing-engaging portion 702 includes first and second
sections 704, 706 secured to one another at a hinge 708. The first and
second sections 704, 706 are each shaped substantially, at least along an
outer periphery, as half cylinders.

[0041]FIG. 1A illustrates an open configuration, in which the first and
second sections 704, 706 are freely pivotable with respect to one another
about the hinge 708. In this configuration, the first section 704 can be
positioned on the IV tubing 34 such that the tubing 34 resides in a
recess 710 in the interior of the first section 704. In the illustrated
embodiment, the recess 710 is shaped substantially as a half cylinder and
is sized to snugly engage the exterior of the IV tubing 34. The second
section 706 similarly includes a recess 710 shaped and sized to snugly
engage the exterior of the IV tubing 34. From the open configuration
shown in FIG. 2, the second section 706 can be pivoted about the hinge
708 to enclose a length of the tubing 34 within the recesses 710 of the
two sections. FIG. 1B illustrates the closed configuration in which the
IV tubing-engaging portion 702 surrounds a length of the tubing 34 and
secures the apparatus 700 to the tubing 34.

[0042] In certain embodiments, the first and second sections 704. 706 may
include a latch, a first portion 712 of which is shown in FIG. 1A. The
latch retains the IV tubing-engaging portion 702 in the closed
configuration to resist removal of the apparatus 700 from the tubing 34.
The structure and function of latches are discussed in further detail
below with respect to alternative embodiments of the present apparatus.

[0043] With reference to FIG. 1B, the recess 710 in the second section 706
includes a first diameter that is selected to enable the second section
706 to snugly engage the exterior of the IV tubing 34, which in one
embodiment includes a slight compression fit. Along a portion of its
length, however, the recess 710 includes a second, larger, diameter that
forms a semi-cylindrical cavity 714. The first section 704 also includes
a cavity 716 positioned opposite the first cavity 714. The second cavity
716 is also semi-cylindrical, but includes a disk-shaped portion 722
opposite the first cavity 714. Each cavity 714, 716 receives a
semi-cylindrical elastomeric sealing member 718, 720. When the IV
tubing-engaging portion 702 is in the closed position, the sealing
members 718. 720 snugly engage a portion of the tubing 34, as shown in
FIG. 1B. As discussed in detail below, the sealing members 718, 720
provide a seal at their interface with the tubing 34 so that liquid does
not leak from around the site where the apparatus 700 punctures the
tubing 34, which is also discussed in detail below. The sealing members
718. 720 may be constructed from silicone, for example, or any other
suitable elastomeric material that is capable of providing a seal against
IV tubing 34. such as a thermoplastic elastomer (TPE). In other
embodiments, the first and second sections 704, 706 are sized and made
with materials that seal against the IV tubing in the absence of a
separate sealing member. In still other embodiments, a sealing member may
be formed around the general area of the puncturing member only.

[0044] With continued reference to FIG. 1 B, a post 724 extends from a
floor of the cavity 714 toward the second section 706 of the IV
tubing-engaging portion 702. A height of the post 724 is equal to a depth
of the cavity 714. An aperture 726 extends through the post 724 and the
first section 704, perpendicularly to a longitudinal axis of the IV
tubing-engaging portion 702. About the aperture 726. the first section
704 includes a ring-shaped boss 728 on its outer surface, which may be
referred to as a branch extending from the first section 704.

[0045] With reference to FIGS. A and 1B. the IV tubing-engaging portion
702 further includes an optional clamp 70 located in an upstream region
of the IV tubing-engaging portion 702. The clamp 70 enables an operator
to pinch the flexible tubing 34 and restrict fluid flow through the
tubing 34. The structure and function of clamp 70 is discussed in further
detail below with respect to alternative embodiments of the present
apparatus.

[0046] With continued reference to FIGS. 1A and 1B, a valve member 730
extends perpendicularly from the first section 704 of the IV
tubing-engaging portion 702. In other embodiments the valve member 730
may extend from the IV tubing-engaging portion 702 at a different angle
than perpendicularly. With reference to FIG. 1B, the valve member 730
includes a substantially cylindrical housing 732 having a female Luer
inlet 734 at its proximal end. A distal end of the housing 732 receives
an adapter 736 that is shaped substantially as a disk having a central
aperture 738. A proximal face of the adapter 736 includes a first
ring-shaped boss 740 about the aperture 726, the boss 740 having a first
diameter. A distal face of the adapter 736 includes a second ring-shaped
boss 742 about the aperture 726, the boss 742 having a second diameter.
The second diameter is smaller than the first diameter. The first
ring-shaped boss 740 seats within the distal end of the housing 732, and
the second ring-shaped boss 742 seats within the ring-shaped boss 728 on
the outer surface of the first section 704 of the IV tubing-engaging
portion 702.

[0047] The housing 732 contains an elastomeric sealing member 744 having a
tubular lumen 746. The sealing member 744, also referred to as a piston
or internal core, controls fluid flow through the inlet of the valve
member 730. A proximal region 748 of the sealing member 744 fills the
inlet 734. thereby sealing the inlet 734. The proximal region 748
includes a transverse slit (not shown) that is compressed on itself by
the relative dimension of the housing 732. The compressed slit seals
fluid from flowing through the lumen 746.

[0048] The lumen 746 in the sealing member 744 contains a puncturing or
piercing member 750. The puncturing member 750 includes a lumen (not
shown) and a pointed distal tip 752. The puncturing member lumen opens to
the distal tip 752, which forms an angle of approximately 45° to a
longitudinal axis of the puncturing member 750, similar to a standard
hypodermic needle. A cylindrical sleeve or holding member 754 receives a
proximal end of the puncturing member 750. An interior of the sleeve 754
engages the puncturing member 750, and an exterior of the sleeve 754 is
held in the lumen 746 of the sealing member 744, just distal of the
proximal region 748. The puncturing member 750 may be secured within the
sleeve 754 with a friction fit, by welding, by adhesive, or by any other
suitable means. Similarly, the sleeve 754 may be secured within the
sealing member 744 with a friction fit, detent, slight compression.
welding, adhesive, other suitable means or combinations thereof to permit
movement to a second position, as further discussed below. In alternative
embodiments, the sleeve 754 may be formed integrally with the puncturing
member 750, or the sleeve 754 may be omitted and the puncturing member
750 may be secured directly to the sealing member 744.

[0049] The puncturing member 750 extends distally from the sleeve 754
through the lumen 746 in the sealing member 744. A distal region of the
puncturing member 750 extends through the apertures 738, 726 in the
adapter 736 and the first section 704 of the IV tubing-engaging portion
702. In certain embodiments, one or both of the apertures 726, 738 may
have a diameter substantially equal to or slightly larger than an outside
diameter of the puncturing member 750. The apertures 726, 738 are thus
able to guide the puncturing member's 750 movement, which is described
below.

[0050] The slit provides a path through the sealing member 744 for a male
Luer connector at the distal end of an injection apparatus, such as a
syringe (not shown). The male Luer connector is securable to the valve
member 730 by engaging internal threads (not shown) on the shroud of the
connector with the external threads 756 on the female Luer inlet 734 of
the valve member 730. A process for connecting an injection apparatus,
such as a syringe, to the valve member 730 is described below.

[0051] The apparatus 700 illustrated in FIGS. 1A and 1B advantageously
creates an injection port at any desired location along a length of IV
tubing. For example. an operator may take an existing length of IV line
that is already in use and create a port for providing flow through the
created port. To establish the port. the operator begins with the
apparatus 700 in the open configuration of FIG. 1A. He or she then
positions the first section 704 of the IV tubing-engaging portion 702
against the IV tubing 34 at the desired location. The first section 704
is positioned such that the tubing 34 rests in the recess 710 of the
first section 704. The operator then pivots the second section 706 about
the hinge 708 to move the IV tubing-engaging portion 702 to the closed
position around the tubing 34, as shown in FIG. 1B. The latch retains the
IV tubing-engaging portion 702 in the closed position. so that the
apparatus 700 does not accidentally disengage the tubing 34.

[0052] The operator next engages an injection apparatus, such as a syringe
(not shown), with the valve member 730. To do so. the operator engages
the male Luer fitting at the distal end of the syringe with the female
Luer inlet 734 at the proximal end of the valve member 730. The internal
threads on the male Luer fitting engage the external threads 756 on the
female Luer inlet 734 as the syringe is rotated in a first direction
relative to the valve member 730. As the male connector is screwed onto
the female connector 734, a nozzle or male tip at the distal end of the
male connector pushes against the proximal region 748 of the sealing
member 744 and compresses the sealing member 744. In one embodiment, the
sealing member 744 buckles in random folds in response to the force of
the male tip. Concurrently. the sleeve 754 and the puncturing member 750
are forced distally. In the configuration shown in FIG. 1B. the distal
tip 752 of the puncturing member 750 is spaced from an outer surface of
the IV tubing 34. However, as the sleeve 754 and the puncturing member
750 are forced distally the pointed distal tip 752 of the puncturing
member 750 is forced through the IV tubing 34. Concurrently, the slit
opens and fluid communication is established between the male Luer
connector and the IV tubing 34 through the sealing member lumen 746.

[0053] When the injection apparatus has been secured to the valve member
730 as described above, the operator may depress a plunger on the
injection apparatus to inject liquid medicament into the IV tubing 34
through the sleeve 754 and the puncturing member 750. In other
embodiments, a hydrophobic filter (not shown) may be used to vent the
lumen 746. During the injection, the operator may occlude liquid flow
upstream from the puncturing member 750 by pinching the clamp 70. The
process of occluding fluid flow using the clamp 70 is described in
further detail below with respect to alternative embodiments.

[0054] When the puncturing member 750 pierces the IV tubing 34, liquid may
flow out of the IV tubing 34 through a puncture created by the puncturing
member 750. The sealing members 718, 720 and the proximal region 748 of
the sealing member 744 resist leakage of this liquid from the apparatus
700. Like the sealing members 718, 720, the sealing member 744 may be
constructed from silicone, for example, or any other suitable elastomeric
material that is capable of providing a seal having a slit. Further, the
second sealing member 720 includes a thickened portion 758 opposite the
aperture 726. The thickened portion 758 provides a backstop for the
distal tip 752 of the puncturing member 750. If the puncturing member 750
should pass entirely through the IV tubing 34, the thickened portion 758
receives the distal tip 752 and forms a seal around the puncture in the
IV tubing 34.

[0055] After performing an injection, the male connector 162 may be
withdrawn from the apparatus by twisting it in the direction opposite
that used to advance the male connector 162 into the sealing member 744.
As the male connector 162 is withdrawn, the sealing member 744 reverts to
its original shape, forcing the proximal region 748 to fit into the inlet
734 of the valve member 730, which forces the walls of the slit to come
together to reseal the proximal end 154 of the sealing member 136. As the
sealing member 744 reverts to its original shape. it draws the sleeve 754
and the puncturing member 750 with it, returning them to the position
shown in FIG. 1B. The puncturing member 750 is thus withdrawn from the IV
tubing 34. Liquid may flow from within the IV tubing 34 through a
puncture left by the puncturing member 750. The sealing members 718, 720
and the proximal region 748 of the sealing member 744 resist leakage of
this liquid from the apparatus 700.

[0056] In another embodiment, as the sealing member 744 reverts to its
original shape, it separates from the sleeve 754. In this embodiment, the
force holding the puncturing member 750 in the pierced IV tubing 34 is
greater than the force holding the sleeve 754 in the sealing member 744,
which may be a simple friction fit. The puncturing member 750 thus
remains pierced to and in fluid communication with the IV tubing 34 while
the seal member returns to its original position. In other embodiments,
the seal member does not include a transverse slit and instead forces
fluid to flow around the outside of the seal member, in the space between
the interior surface of the housing 732 and the outside exterior surface
of the seal member. Provisions are made to then direct fluid flow through
the piercing member, such by placing the inlet to the piercing member
below the valve and creating flow channels to direct flow into the inlet
of the piercing member.

[0057]FIG. 1 illustrates another embodiment of the present apparatus 30
for selectively establishing a needleless injection port on intravenous
(IV) tubing 34. The apparatus 30 includes an IV tubing-engaging portion
or saddle 32 configured to at least partially surround a portion of the
IV tubing 34 to secure the apparatus 30 to the tubing 34. The tubing 34
is, or can be, connected to an IV supply source. such as a diluent or IV
solution, and/or to a patient. With reference to FIG. 2, which
illustrates another embodiment of the present apparatus 40, the IV
tubing-engaging portion 42 includes first and second sections 44, 46
secured to one another at a hinge 48. The first and second sections 44,
46 are each shaped substantially, at least along an outer periphery, as
half cylinders.

[0058] The hinge 48 comprises first cylindrical hinge parts 50 extending
from an edge of the second section 46 and a second cylindrical hinge part
52 extending from an edge of the first section 44. The second hinge part
52 resides between the first hinge parts 50 and is rotatable relative to
the first hinge parts 50. In certain embodiments a hinge pin (not shown)
may extend through the hinge parts 50, 52 to rotatably secure them
together. In certain other embodiments the hinge parts 50, 52 may include
structural features, such as interconnected posts and recesses 54, that
rotatably secure them together without or in addition to the hinge pin.

[0059]FIG. 2 illustrates an open configuration, in which the first and
second sections 44, 46 are freely pivotable with respect to one another
about the hinge 48. In this configuration, the first section 44 can be
positioned on the IV tubing 34 such that the tubing 34 resides in a
recess 54 in the interior of the first section 44. In the illustrated
embodiment, the recess 54 is shaped substantially as a half cylinder and
is sized to snugly engage the exterior of the IV tubing 34. The second
section 46 similarly includes a recess 54 shaped and sized to snugly
engage the exterior of the IV tubing 34. From the open configuration
shown in FIG. 2. the second section 46 can be pivoted about the hinge 48
to enclose a length of the tubing 34 within the recesses 54 of the two
sections. FIG. 1 illustrates the closed configuration in which the IV
tubing-engaging portion 32 surrounds a length of the tubing 34 and
secures the apparatus 30 to the tubing 34, similar to when the first and
second sections 44, 46 of the saddle 42 of FIG. 2 are engaged with one
another.

[0060] In certain embodiments, the first and second sections 44, 46 may
include a latch 56 (FIG. 2) that retains the IV tubing-engaging portion
32 in the closed configuration to resist removal of the apparatus 30 from
the tubing 34. In certain further embodiments, the latch 56 may be
configured to resist opening so that the apparatus 30 cannot be removed
from the tubing 34 without damaging the apparatus 30 and/or the tubing
34. In the embodiment of FIG. 2, a first latch part 58 comprises a
cantilevered extension from the sidewall of the first section 44. An
inner surface of the first latch part 58 includes an inwardly extending
flange 60. The second section 46 includes a second latch part comprising
a recess 62. The recess 62 is sized and shaped to receive the first latch
part 58. The recess 54 includes a ramp 64 and a flange-receiving space
located behind the ramp 64. When the second section is 46 moved toward
the closed configuration, the flange 60 contacts the ramp 64, which
increasingly bends the first latch part 58 outward as the flange 60 rides
farther up the ramp 64. When the flange 60 passes over the top of the
ramp 64, it snaps into the flange-receiving space behind the ramp 64. In
the closed configuration, the flange 60 bears against a rear surface of
the ramp 64, resisting movement of the first latch part 58 out of the
recess 54, which in turn resists movement of the IV tubing- engaging
portion 32 toward the open configuration.

[0061] With reference again to FIG. 2, the recess 54 in the second section
46 includes a first diameter that is selected to enable the second
section 46 to snugly engage the exterior of the IV tubing 34, which in
one embodiment includes a slight compression fit. Along a portion of its
length. however, the recess 54 includes a second, larger, diameter that
forms a semi-cylindrical cavity 66. With reference to FIG. 3, the first
section 44 includes a semi-cylindrical cavity 66 that is a mirror image
of the cavity 66 in the second section 46. Each cavity 66 receives a
semi-cylindrical elastomeric sealing member 68. When the IV
tubing-engaging portion 32 is in the closed position, the sealing members
68 snugly engage a portion of the tubing 34, as shown in FIG. 3. As
discussed in detail below, the sealing members 68 provide a seal at their
interface with the tubing 34 so that liquid does not leak from around the
site where the apparatus 30, 40 punctures the tubing 34, which is also
discussed in detail below. The sealing members 68 may be constructed from
silicone, for example. or any other suitable elastomeric material that is
capable of providing a seal against IV tubing 34. such as a thermoplastic
elastomer (TPE).

[0062] With reference to FIG. 1, the IV tubing-engaging portion 32 further
includes an optional clamp 70 located in an upstream region of the IV
tubing-engaging portion 32. The clamp 70 comprises first and second push
buttons 72 extending outward in opposite directions from the IV
tubing-engaging portion 32. With reference to FIG. 2, each of the push
buttons 72 is cantilevered to one of the first and second sections 44.
46. A clamp part 74 extends inwardly from the underside of each push
button 72. When the IV tubing-engaging portion 32 is in the closed
position (FIG. 1), the clamp parts 74 bear lightly against, or are spaced
from, the tubing 34. When an operator squeezes the push buttons 72 toward
one another. the clamp parts 74 move toward one another, pinching the
flexible tubing 34 and restricting fluid flow through the tubing 34. If
the operator applies sufficient force, he or she can completely occlude
fluid flow.

[0063] As described in further detail below, the operator may occlude
fluid flow at a location upstream from an injection site prior to giving
the injection through the apparatus 30, 40. Occluding fluid flow upstream
from the injection site causes the injected fluid to flow to the patient,
rather than upstream through the IV line. In certain embodiments, the
clamp 70 may include a releasable latch (not shown) to temporarily lock
the clamp parts 74 in an occluding position so that the operator does not
have to hold the clamp 70 with one hand while giving an injection with
the other hand.

[0064] With reference to FIG. 1, a tubular branch portion 76 extends
perpendicularly from the IV tubing-engaging portion 32. In other
embodiments the branch portion 76 may extend from the IV tubing-engaging
portion 32 at a different angle than perpendicularly. With reference to
FIG. 3, the branch portion 76 includes a lumen 78 and an external thread
80 at its proximal end 82. The sealing member 68 seals the distal end 84
of the lumen 78. A substantially disk-shaped protrusion 86 extends from
the sealing member 68 toward the lumen 78. A proximal surface 88 of the
protrusion 86 abuts the distal end 84 of the lumen 78. providing a seal.
A flange 90 extends around the proximal edge of the protrusion 86. An
annular recess 92 in the interior sidewall of the first section 44
receives the flange 90. Engagement of the flange 90 and the annular
recess 92 retains the sealing member 68 within the recess 66 when the
apparatus 30, 40 is in the open configuration (FIG. 2).

[0065] With reference to FIGS. 1-3, a piston portion 94 engages the branch
portion 76. With reference to FIG. 3. the piston portion 94 includes a
central shaft 96 having a distal region 98 disposed within the lumen 78
of the branch portion 76. A lumen 100 extends completely through the
central shaft 96. A puncturing member 102 extends distally from the
central shaft 96. The puncturing member 102 includes a lumen (not shown)
and a pointed distal tip 104. The puncturing member 102 may extend at
least partially through the lumen 100 in the central shaft 96. A distal
region of the puncturing member 102 includes at least one opening 106. In
the illustrated embodiment, the opening 106 is in a sidewall of the
puncturing member 102. In alternative embodiments, the distal end of the
puncturing member 102 may be open. as in a standard hypodermic needle.

[0066] With continued reference to FIG. 3, the piston portion 94 further
includes a cylindrical outer wall 108 separated from the central shaft 96
by an annular space 110. A proximal end wall 112 connects the outer wall
108 and the central shaft 96. An inner surface of the outer wall 108
includes threads 114 that engage the external thread 80 on the branch
portion 76. Due to the engagement of the threads 80, 114. rotation of the
piston portion 94 in a first direction relative to the branch portion 76
advances the piston portion 94 distally, as explained in further detail
below.

[0067] With reference to FIG. 3A, an exterior surface of the outer wall
108 includes an annular flange 116 near its distal end 118. The annular
flange 116 resists accidental disengagement of the piston portion 94 from
the branch portion 76, as described in further detail below.

[0068] With continued reference to FIG. 3A, the apparatus 30 further
includes a stabilizer 121 for the piston portion 94. The stabilizer
comprises first and second uprights 122 that extend outwardly from the
first section 44 of the IV tubing-engaging portion 32 on opposite sides
of the piston portion 94. Each of the uprights 122 is shaped
substantially as a right triangle. with a long leg 124 extending along
the piston portion 94 and a short leg 126 extending along the first
section 44. With reference to FIGS. 2 and 3A, a transverse wall 128
extends perpendicularly outward in both directions from the plane defined
by each upright 122 along the long leg 124. A flange 130 (FIG. 3A)
extends toward the piston portion 94 at the proximal end of each upright
122. The uprights 122 help to stabilize the piston portion 94 by
resisting side-to-side tilting of the piston portion 94 as it is rotated
relative to the branch portion 76.

[0069] With continued reference to FIG. 3A, a spacing between the uprights
122 is substantially equal to an outer diameter of the annular flange 116
on the outer wall 108. A spacing between the flanges 130 on the uprights
122 is substantially equal to an outer diameter of the outer wall 108.
The flanges 130 thus form a barrier that resists accidental disengagement
of the piston portion 94 from the branch portion 76. A distal surface 132
of the annular flange 130 is oriented at an angle to the outer sidewall
108 of the piston portion 94. Similarly, a proximal surface 134 of each
flange 130 is oriented at an angle to its respective transverse wall 128.
The surfaces 132, 134 form ramps that engage one another and force the
uprights 122 outward to enable the piston portion 94 to be screwed onto
the branch portion 76. In one embodiment, the angles of the ramps 132,
134 are equal.

[0070] With continued reference to FIG. 3A, a valve member 136 engages a
proximal end 138 of the piston portion 94. A nut 148 located at the
distal end of the valve member 136 includes a central disk-shaped
protrusion 140 that seats in a complementary recess 142 at the proximal
end 138 of the piston portion 94. The valve member 136 further includes a
generally cylindrical housing 144 attached to the nut 148. The housing
144 has a female Luer inlet 146 at its proximal end. The nut 148 includes
a lumen 150 that adjoins a proximal end of the lumen 100 in the central
shaft 96. In one embodiment, the nut 148 is a separate piece secured to
the outer wall 108 of the piston 94. In another embodiment, the nut 148
and the outer wall of the piston 94 are a single integral piece.

[0071] The housing 144 contains an elastomeric sealing member 158 having a
tubular lumen 152. The sealing member 158, also referred to as a piston
or internal core, controls fluid flow through the valve member 136 and
consequently through the shaft 96. A proximal region 160 of the sealing
member 158 is sealed by the relative dimension of the inlet 146. which
forces a transverse slit (not shown) in the sealing member 158 to
compress on itself and seal fluid from flowing through the lumen 152.

[0072] The slit provides a path through the sealing member 158 for a male
Luer connector 162 (FIG. 1) at the distal end of an injection apparatus,
such as a syringe 164. The male Luer connector 162 is securable to the
valve member 136 by engaging internal threads (not shown) on the shroud
of the connector 162 with the external threads 166 on the female Luer
connector 146 of the valve member 136. As the male connector 162 is
screwed onto the female connector 146, a nozzle or male tip 168 (FIG. 1)
at the distal end of the male connector 162 pushes against the proximal
region of the sealing member 158 and compresses the sealing member. In
one embodiment, the sealing member 158 buckles in random folds in
response to the force of the male tip 168. Concurrently, the slit opens
and fluid communication is established between the lumen 152 of the
sealing member 158, the male Luer connector 162, the lumens 100, 150, and
the lumen in the puncturing member 102. When the male connector 162 is
withdrawn, the sealing member 158 reverts to its original shape, forcing
the proximal region 160 to fit into the inlet 146 of the valve member
136, which forces the walls of the slit to come together to reseal the
proximal end 154 of the sealing member 136. The sealing member 158 may be
constructed from silicone, for example, or any other suitable elastomeric
material that is capable of providing a seal having a slit.

[0073] The apparatus 30, 40 illustrated in FIGS. 1-3 advantageously
creates an injection port at any desired location along a length of IV
tubing. For example, an operator may take an existing length of IV line
that is already in use and create a port for providing flow through the
created port. To establish the port, the operator begins with the
apparatus 30, 40 in the open configuration. He or she then positions the
first section 44 of the IV tubing-engaging portion 32 against the IV
tubing 34 at the desired location. The first section 44 is positioned
such that the tubing 34 rests in the recess 54 of the first section 44,
as shown in FIG. 2. The operator then pivots the second section 46 about
the hinge 48 to move the IV tubing-engaging portion 32 to the closed
position around the tubing 34, as shown in FIG. 1. The latch 56 retains
the IV tubing-engaging portion 32 in the closed position. so that the
apparatus 30 does not accidentally disengage the tubing 34.

[0074] The operator next engages an injection apparatus, such as a syringe
164, with the valve member 136. To do so, the operator engages the male
Luer fitting 162 at the distal end of the syringe 164 with the female
Luer fitting 146 at the proximal end 156 of the valve member 136. The
internal threads on the male Luer fitting 162 engage the external threads
166 on the female Luer fitting 146 as the syringe 164 is rotated in a
first direction relative to the valve member 136. The nozzle 168 on the
male Luer fitting 162 advances against the proximal surface of the
sealing member and opens the slit establishes fluid communication between
the syringe 164 and the lumens 100, 150, 152 and the lumen in the
puncturing member 102.

[0075] When the male Luer fitting 162 has been completely screwed into the
valve member 136, a distal annular shoulder 170 on the shroud of the male
Luer fitting 162 engages a proximal annular shoulder 172 on the female
Luer fitting 164 (FIG. 1). Any further rotation of the syringe 164 in the
first direction induces rotation of the valve member 136 and piston
portion 94 relative to the branch portion 76. However, prior to advancing
the piston portion 94 distally into the branch portion 76, the operator
preferably purges air from the lumens 100, 150, 152 and the lumen in the
puncturing member 102. The purging step may be performed several
different ways, as described below with respect to various embodiments
configured for various different purging methods.

[0076] After purging the air from the lumens 100, 150. 152 and the lumen
in the puncturing member 102, the operator rotates the syringe 164. the
valve member 136 and the piston portion 94 in the first direction
relative to the branch portion 76 to advance the piston portion 94
distally with respect to the branch portion 76. The advancing piston
portion 94 drives the pointed tip 104 (FIG. 3) of the puncturing member
102 through the elastomeric sealing member 68 and through a sidewall of
the IV tubing 34 to establish fluid communication between an interior of
the IV tubing 34 and the lumen in the puncturing member 102. The sealing
member 68 seals around the puncturing member 102 and the opening in the
tubing 34 to prevent liquid from leaking through the interface of the
puncturing member 102 and the opening. With fluid communication
established, the operator can inject liquid from the syringe 164 into the
IV tubing 34 by depressing a plunger (not shown) on the syringe 164. To
restrict the injected liquid from flowing upstream in the IV tubing 34,
the operator can pinch the clamp 70 upstream from the injection site
while depressing the plunger. In an alternative embodiment. the
puncturing member 102 punctures the IV tubing by rotating the valve
member 136 without having to first engage a syringe to the valve member.

[0077] After completing the injection, the operator simply rotates the
syringe to separate it from the valve member 136. The valve member
remains in the active position, in which the puncturing member 102
projects into the IV tubing 34. The sidewalls on either side of the slit
come together after the syringe is removed to reseal the proximal end 154
of the tubular member 152. The port 30, 40 is then ready for reuse at any
time by simply inserting the syringe into the inlet of the valve member
to open the slit. Thus, one aspect of the present embodiments is an
apparatus for selectively creating an access port along a length of IV
tubing to enable fluid communication between the port and the IV tubing.
In a particular embodiment, the fluid communication is created in a
sidewall of the IV tubing by puncturing the wall of the IV tubing. As a
specific example, the apparatus for forming a port along a length of IV
tubing comprises a saddle having a bore for accommodating the tubing, a
branch nozzle extending from the saddle comprises a lumen; a piston
portion comprising a lumen engageable with the branch nozzle so that the
two lumens communicate; and a valve member comprising a housing having an
inlet port and a sealing member disposed therein; wherein a puncturing
member is disposed with the piston member so that a shaft of the
puncturing member is coaxial with the piston member; and wherein the
puncturing member comprises a sharp distal tip for puncturing the IV
tubing.

[0078] In an alternative embodiment (not shown), the IV tubing-engaging
portion may not include first and second hinged sections. Instead, the IV
tubing-engaging portion may comprise a single piece having a cylindrical
longitudinal opening sized to snugly fit the tubing 34. This embodiment
could be combined with IV tubing 34 during manufacture, or by a medical
professional prior to establishing the IV line in the patient. The
alternative apparatus could be moved along the IV line to any convenient
location, and only used if needed. If unused, the alternative apparatus
could later be removed from the IV line after it is removed from the
patient so that the alternative apparatus could be used again with a
different IV line in a later procedure.

[0079] FIGS. 4 and 5 illustrate another alternative embodiment of the
present apparatus 200 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 4 and 5 is similar to the
embodiments of FIGS. 1-3. Accordingly, the description of the apparatus
200 herein will focus on the differences in structure between the
embodiments. The apparatus 200 of FIGS. 4 and 5 includes a branch portion
202 extending perpendicularly from an IV tubing-engaging portion 204. The
branch portion 202 includes internal threads 206, a first external flange
208 at a proximal end 207 and a second external flange 209 spaced
distally from the first external flange 208. Each of the flanges includes
a ramped proximal edge 211, 213 and a distal edge 215, 217 that extends
perpendicularly to the branch portion 202.

[0080] The apparatus 200 further includes a piston portion 210 engaging
the branch portion 202. The piston portion 210 includes a central shaft
212 having external threads 214 that mate with the internal threads 206
in the branch portion 202. Rotating the piston portion 210 in a first
direction relative to the branch portion 202 causes the piston portion
210 to advance distally with respect to the branch portion 202, driving
the puncturing member 102 through the sealing member and the IV tubing,
as shown in FIG. 5.

[0081] The piston portion 210 further includes a cylindrical outer wall
216 separated from the central shaft 212 by an annular space 218. An
interior surface 220 of the outer wall 216 includes an annular flange 222
having a ramped distal edge 224 and a proximal edge 226 that extends
perpendicularly to the interior surface 220. When the apparatus 200 is in
the configuration of FIG. 4, the distal edge 215 (FIG. 5) of the first
flange 208 presents a barrier to the annular flange 222 on the outer wall
216, resisting proximal movement of the piston portion 210 relative to
the branch portion 202. The flanges 208, 222 thus resist removal of the
piston portion 210 from the branch portion 202.

[0082] When the piston portion 210 is rotated in the first direction
relative to the branch portion 202, the ramped edges 213, 224 (FIG. 5) of
the second flange 209 and the annular flange 222 ride up over one another
as the piston portion 210 advances distally with respect to the branch
portion 202. When the annular flange 222 passes the second flange 209, it
snaps into place beneath the second flange 209, as shown in FIG. 5. The
distal edge 217 (FIG. 4) of the second flange 209 presents a barrier to
the annular flange 222 on the outer wall 216, resisting proximal movement
of the piston portion 210 relative to the branch portion 202. The
apparatus 200 is thus locked in a ready-to-use configuration in which the
puncturing member 102 penetrates the IV tubing 34.

[0083] FIGS. 6 and 7 illustrate another alternative embodiment of the
present apparatus 300 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 6 and 7 is similar to the
embodiment of FIGS. 4 and 5. In the embodiment of FIGS. 6 and 7, however,
the sealing member 68 is located on only the proximal side of the IV
tubing 34. The sealing member 68 is located on the same side of the IV
tubing 34 as the puncturing member 102. There is no corresponding sealing
member 68 on the distal side of the IV tubing 34 opposite the puncturing
member 102. The sealing member 68 nonetheless provides a leak-proof seal
around the IV tubing 34 and the puncturing member 102 in the area where
the puncturing member 102 punctures the IV tubing 34.

[0084] FIGS. 8 and 9 illustrate another alternative embodiment of the
present apparatus 400 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 8 and 9 is similar to the
embodiment of FIGS. 4 and 5. In the embodiment of FIGS. 8 and 9, however,
neither the branch portion 402 nor the piston portion 404 includes
threads. Instead, the branch portion 402 is shaped substantially as a
smooth cylinder. The piston portion 404 includes a central shaft 406 that
is also shaped substantially as a smooth cylinder and sized to fit within
the branch portion 402. The piston portion 404 further includes a
cylindrical outer wall 408 separated from the central shaft 406 by an
annular space 410. The annular space 410 is sized to receive the branch
portion 402 when the piston portion 404 is advanced distally with respect
to the branch portion 402, as shown in FIG. 9.

[0085] In the embodiment of FIGS. 8 and 9. since neither the branch
portion 402 nor the piston portion 404 includes threads, the piston
portion 404 may be advanced distally with respect to the branch portion
402 by simply applying a pushing force to the piston portion 404. When
the piston portion 404 advances far enough that the puncturing member 102
pierces the IV tubing 34 and the opening 106 in the puncturing member 102
is disposed within the IV tubing 34, a latching mechanism (not shown) on
the branch portion 402 and the piston portion 404 may engage to restrict
movement of the piston portion 404 proximally with respect to the branch
portion 402, such as latching detents and interference knuckles or tabs.

[0086] With reference to FIG. 9, the puncturing member 102 passes
completely through the IV tubing 34. However, the opening 106 is disposed
within the IV tubing 34. Advancement of the puncturing member 102 may be
controlled by providing physical stops or corresponding mating abutting
surfaces between the various components, such as between the central
shaft 406 and the sealing member 68. Thus, any liquid injected through
the puncturing member 102 will pass into the IV tubing 34. rather than
through it. Further, the apparatus 400 includes sealing members 68 that
surround the IV tubing 34 in the area of the puncturing member 102. The
sealing member 68 thus seals around both punctures in the IV tubing 34 to
resist leakage of fluid from the IV tubing 34.

[0087] FIGS. 10, 10A, 10B. 10C, 11 and 12 illustrate another alternative
embodiment of the present apparatus 500 for selectively establishing a
needleless injection port on IV tubing 34. The embodiment of FIGS. 10,
10A, 10B, 10C, 11 and 12 is similar to the embodiment of FIGS. 8 and 9.
The embodiment of FIGS. 10, 10A, 10B, 10C, 11 and 12, however, includes a
priming channel 502. With reference to FIG. 10A, the priming channel 502
extends through the sealing member 504 in a direction transverse to the
puncturing member 102 and transverse to a longitudinal axis of the IV
tubing-engaging portion 506 but may alternatively be parallel. The
priming channel 502 is located on the proximal side of the IV tubing 34
when the apparatus 500 is secured to the IV tubing 34.

[0088] With continued reference to FIG. 10A, a first end of the priming
channel 502 comprises an aperture 510 in the first section 512 of the IV
tubing-engaging portion 506. The aperture 510 adjoins a recess 514 in the
outer surface of the first section 512. The recess 514 includes an
annular shoulder 516 that retains a hydrophobic porous membrane 518. The
porous membrane 518 includes openings (not shown) that are configured to
enable gaseous particles (such as the constituents of air) to pass, but
not liquid particles (such as water). The membrane 518 thus provides a
partial seal over the priming channel 502 by enabling air, but not
liquid, to escape the interior of the apparatus 500. Hydrophobic filters
can be made from a number of suitable materials well known to one skilled
in the art, such as from super hydrophobic polyvinyldiflouride (PVDF).

[0089] With continued reference to FIG. 10A, the sealing member 504 on the
proximal side of the IV tubing 34 includes a recess 520 that is sized and
shaped to receive the distal region 522 of the puncturing member 102. The
recess 520 is slightly larger in diameter than the puncturing member 102
so that the sealing member 504 does not form a seal over the opening 106
in the puncturing member 102 when the distal region 522 of the puncturing
member 102 is disposed in the recess 520.

[0090] When the distal region 522 of the puncturing member 102 is disposed
in the recess 520 as shown in FIG. 10A, the apparatus 500 may be primed
as follows. The operator connects a syringe (not shown) to the valve
member 136 (FIGS. 10 and 11) in the manner described above with respect
to the embodiments of FIGS. 1-3. The operator then injects liquid from
the syringe into the apparatus 500. The injected liquid enters the lumens
100, 150. 152 (See e.g., FIG. 3A) and the lumen in the puncturing member
102 and displaces any air contained there. With reference to FIG. 10A,
the air flows from the lumens out the opening 106 in the distal region of
the puncturing member 102, into the priming channel 502, and finally out
through the porous membrane 518. The membrane 518 allows gaseous
particles to pass, but not liquid. Thus, the inflowing liquid forces all
(or substantially all) entrained air in the lumens and the priming
channel 502 and recess 520 out of the apparatus 500.

[0091] Once the air is forced out, the operator can advance the piston
portion 526 with respect to the branch portion 524 in order to pierce the
IV tubing 34, and then proceed to inject liquid medicine. The operator
may, for example, inject medicine using the same syringe that he or she
used to prime the apparatus 500. Alternatively, the operator may prime
the apparatus 500 with a first syringe containing, for example, saline.
The operator may then disconnect the first syringe from the valve member
136, connect a second syringe to the valve member 136, and make the
injection using the second syringe. However, as air space or dead space
inside the valve member is relative small, purging is not believed to be
mandatory.

[0092] With embodiments of the present apparatus that do not include a
priming channel 502. an operator can still prime the apparatus prior to
injection as follows. With reference to FIG. 5. for example, the operator
advances the piston portion 210 distally relative to the branch portion
202 until the opening 106 in the distal region of the puncturing member
102 is disposed within the IV tubing 34. The operator can perform this
step before or after connecting a syringe to the valve member 136. With
the syringe connected, the operator draws back on the syringe plunger to
withdraw liquid from the interior of the IV tubing 34. The liquid flows
through the lumens, forcing air out and into the syringe. When the
operator observes that liquid begins to flow into the syringe from the
apparatus 500, he or she knows that all (or substantially all) of the air
has been expelled from the lumens. The operator then disconnects the
syringe. However, purging may be eliminated altogether due to the
relatively small head space.

[0093] If the syringe contains the medicine to be injected, the operator
orients the syringe with its outlet port facing upward so that the air in
the syringe migrates upward. He or she then expels the air from the
syringe, reconnects the syringe to the valve member, and injects the
medicine. Alternatively, if the syringe is empty or contains a liquid
other than the medicine to be injected, the operator discards the syringe
and connects a different syringe (containing the medicine) to the valve
member. The operator then injects the medicine.

[0094] With reference to FIGS. 10, 10B, 10C, 11 and 12, the apparatus 500
further includes a latching mechanism configured to retain the apparatus
500 in the configuration of FIG. 11. With particular reference initially
to FIG. 10, first and second cavities 528 extend longitudinally and
transversely through the central shaft 530 of the piston portion 526 on
either side of the puncturing member 102. In one embodiment, shown
particularly in FIG. 10B, the cavities 528 marked a divide of the central
shaft 530 as first and second cantilevered. distally extending legs 532.
Each of the legs 532 includes surface features, described below, on its
outer surface. Said differently, in the present embodiment. the central
shaft 530 is shaped as two cantilevered extending legs having gaps
therebetween. In other embodiments, as further discussed below, the
central shaft is shaped as a generally elongated cylinder.

[0095] With reference to FIG. 10B, the surface features include a tab 534
having a ramped distal surface 536 and a proximal surface 538 extending
perpendicularly to the leg 532. First recesses 540 in the branch portion
524 receive the tabs 534. The first recesses 540 include ramped distal
surfaces 542 so that when the operator applies force to the piston
portion 526 to advance it distally with respect to the branch portion 524
the engagement of the ramped surfaces 536, 542 urges the legs 532 to bow
inwardly, disengaging the tabs 534 from the first recesses 540. When the
piston portion 526 approaches the position shown in FIG. 11, the tabs 534
engage cantilevered arms 544, shown in FIG. 12. The cantilevered arms 544
are formed by cutouts 550 in the sidewall of the branch portion 524 that
are positioned behind the cantilevered arms 544. The cantilevered arms
544 extend into the path of the tab 534 as it moves distally, as shown in
FIG. 12. Thus, when the tab 534 engages the cantilevered arms 544 it
bends them outwardly into the cutouts 550, thereby clearing a path for
the tab 534. When the tab 534 reaches the space 551 beneath the
cantilevered arms 544, the arms 544 snap back to their original shape and
block the return path of the tab 534. Engagement of the cantilevered arms
544 with the tabs 534 thus resists proximal movement of the piston
portion 526 with respect to the branch portion 524. The tabs 534 and
cantilevered arms 544 thus hold the apparatus 500 in the configuration of
FIG. 11, in which the opening 106 in the distal region of the puncturing
member 102 is disposed within the IV tubing 34.

[0096] FIGS. 10C and 12A illustrate an alternative embodiment in which the
tabs 535 include distal surfaces 537 that are not ramped. The distal
surfaces 537 engage frangible tabs 539 on the branch portion 524. When
the operator applies a distally directed force to the piston portion 541,
the tabs 535 bear against the frangible tabs 539. which snap off when a
threshold force is reached. The piston portion 541 then advances distally
until the tabs 535 become entrained beneath the cantilevered arms 544 as
described above with respect to FIGS. 10B and 12. In the embodiment of
Figures IOC and 12A , the first and second cavities 528 may or may not
divide the piston portion 541 into first and second legs, as in the
previous embodiment.

[0097] With reference to FIGS. 10 and 11, the apparatus 500 further
includes an alternative hinge 552 connecting the first and second
sections 554, 556 of the IV tubing-engaging portion 506. In contrast to
the hinge 48 of the previous embodiments, which includes first and second
cylindrical hinge parts 50, 52. the hinge 552 of FIGS. 10 and 11 is a
living hinge. A living hinge is a thin flexible member that joins two
rigid parts together, allowing them to bend along the line of the hinge.
Those of ordinary skill in the art will appreciate that the living hinge
552 of the illustrated embodiment is not limited to any particular
material or method of manufacture.

[0098] FIGS. 13 and 14 illustrate another alternative embodiment of the
present apparatus 600 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 13 and 14 is similar to the
embodiments described above, but includes a priming valve 602. The
priming valve 602 comprises a stepped cylinder including a distal region
604 and a proximal region 606. With reference to FIG. 14. the distal
region 604 comprises a male nozzle 608 having a tapered outer surface 610
that is configured to penetrate the valve member 136. The proximal region
606 comprises a female connector 612 having a tapered inner surface 614
that is configured to receive a male nozzle on a syringe (not shown). An
annular shoulder 616. comprising an abrupt change in diameter, demarcates
the junction of the distal and proximal regions 604, 606. The annular
shoulder 616 supports a porous membrane 618. which is similar in
structure and function to that described above. In a specific embodiment,
the tapered surfaces are formed as Luer tapered surfaces.

[0099] To prime the apparatus 600 using the priming valve 602, an operator
inserts the male nozzle 608 into the valve member 136 to open fluid
communication through the sealing member 158. The operator then engages a
syringe (not shown) with the female connector 612 to achieve a seal
between a tapered outer surface of a male nozzle of the syringe and the
tapered inner sidewall 614 of the female connector 612. The operator then
advances the piston portion 620 with respect to the branch portion 622 to
pierce the IV tubing 34 with the puncturing member 102. Those of ordinary
skill in the art will appreciate that the previously described steps may
be performed in any order. Also, the piercing member may be advanced to
puncture the IV tubing without having to first insert the valve opener
and/or the syringe or other medical implement.

[0100] With the puncturing member 102 piercing the IV tubing 34, the male
nozzle 608 opening fluid communication through the sealing member 158,
and the syringe connected to the priming valve 602, the operator then
pulls back on a plunger of the syringe to draw air out of the lumens.
Liquid flowing out of the IV tubing 34 forces the air out of the lumens,
through the porous membrane 618 and into the syringe. Since the membrane
618 will not allow liquid particles to pass, the operator knows that all
(or substantially all) of the air has been expelled from the lumens when
the force required to draw back the plunger increases sharply. The
operator then withdraws the syringe from the priming valve 602 and
withdraws the priming valve 602 from the valve member 136. He or she then
injects medicine using the syringe (or a second syringe) as described
above with respect to the previous embodiments.

[0101] In the illustrated embodiment, a tether 624 secures the priming
valve 602 to the apparatus 600. As shown, the tether 624 is molded as a
single piece with the priming valve 602, and is secured to the piston
portion 620 at an end spaced from the priming valve 602. Those of
ordinary skill in the art will appreciate that the illustrated
configuration for the tether 624 is only one example. Those of ordinary
skill in the art will further appreciate that in embodiments including a
priming valve 602 a tether 624 is optional.

[0102] The apparatus 600 of FIGS. 13 and 14 further includes indicia 626
(FIG. 13) that assist the operator in properly positioning the apparatus
600 on the IV tubing 34. In the illustrated embodiment, the indicia 626
comprises at least one arrow. The arrow indicates the desired direction
of flow through the apparatus 600, so that the clamp 70 is positioned at
the upstream end of the apparatus 600. Those of ordinary skill in the art
will appreciate that any of the embodiments described herein may also
include indicia.

[0103] FIGS. 15-17 illustrate another alternative embodiment of the
present apparatus 800 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 15-17 is similar to the
embodiment described above and illustrated in FIGS. 8 and 9. However, as
shown in FIG. 15 the branch portion 802 of the apparatus 800 includes
first and second tabs 804 at its proximal end 806. The tabs 804 extend
outwardly from opposite sides of the proximal end 806 but may be placed
at different locations in other embodiments.

[0104] With reference to FIG. 16, a sidewall 809 of the piston portion 808
of the apparatus 800 includes an L-shaped channel 810 that receives one
of the tabs 804, as shown in FIG. 17. While not shown in the figures, the
sidewall 809 includes a second L-shaped channel opposite the illustrated
channel 810, or at a location that corresponds to the second tab on the
branch portion 802. The second L-shaped channel receives the other tab
804. Those of ordinary skill in the art will appreciate. however, that in
alternative embodiments the branch portion 802 may include only one tab
804 and the piston portion 808 may include only one L-shaped channel 810.
In still further alternative embodiments, the the branch portion 802 may
include more than two tabs 804 and the piston portion 808 may include a
corresponding number of L-shaped channels 810.

[0105] With reference to FIG. 16, the L-shaped channel 810 includes a
first branch 812 that extends circumferentially about the sidewall 809
and a second branch 814 that extends longitudinally along the sidewall
809. The first branch 812 is located adjacent a distal end 813 of the
piston portion 808. The first and second branches 812, 814 connect at a
ninety-degree angle at an end of each branch, with the second branch 814
extending proximally along the sidewall 809 from the first branch 812.
The channel 810 extends completely through the sidewall 809, and has a
substantially constant width. However, the first branch 812 includes a
boss 816 that narrows the width of the first branch 812 in the region of
the boss 816. The boss 816 is flat on top. and ramped on either side.

[0106] With reference to FIG. 17, when the piston portion 808 is located
at its proximal extreme along the branch portion 802, the first branch
812 receives the tab 804. The tab 804 provides a barrier preventing the
piston portion 808 from translating distally along the branch portion
802. A pushing force applied to the piston portion 808 in a distal
direction causes the tab 804 to bear against the proximal wall 817 of the
first branch 812. The tab 804 and the first branch 812 thus resist
accidental distal translation of the piston portion 808 along the branch
portion 802.

[0107] The tab 804 and boss 816 provide additional resistance to
accidental distal translation of the piston portion 808 along the branch
portion 802. When the apparatus 800 is shipped, the tab 804 is located on
an opposite side of the boss 816 from the second branch 814. The tab 804,
the first branch 812 and the boss 816 are all shaped and dimensioned so
that the boss 816 provides a surmountable barrier to movement of the tab
804 through the first branch 812. Thus, when the operator rotates the
piston portion 808 about the branch portion 802, the tab 804 rides up
over the boss 816 and squeezes through the narrow width of the first
branch 812 in the region of the boss 816. As the operator continues
rotating the piston portion 808 in the same direction about the branch
portion 802, the tab 804 eventually reaches the distal end 818 of the
second branch 814. The tab 804 can then slide freely through the second
branch 814 as the piston portion 808 translates distally along the branch
portion 802.

[0108] FIGS. 18 and 19 illustrate another alternative embodiment of the
present apparatus 900 for selectively establishing a needleless injection
port on IV tubing. The embodiment of FIGS. 18 and 19 is similar to the
embodiment described above and illustrated in FIGS. 15-17. However, as
shown in FIG. 19 the L-shaped channels 902 in the piston portion 904 do
not pass completely through the sidewall 906. Only one of the channels
902 is visible in FIG. 19.

[0109] A first branch 908 of the channel 902 includes a boss 910 that
functions in the same manner as the boss 816 described above with respect
to FIGS. 15-17. However, in the piston portion 904 of FIG. 19 the boss
910 is located at the interior corner of the intersection of the first
branch 908 and the second branch 912.

[0110] With continued reference to FIG. 19, the second branch 912 includes
a detent 914 in its floor 916. The detent 914 is spaced from a proximal
end 918 of the second branch 912, and includes a ramped distal surface
920. A proximal surface 922 of the detent 914 is oriented perpendicularly
to the floor 916. The detent 914 thus enables the tab 804 to ride over
the ramped distal surface 920 and snap into place proximally of the
detent 914 where the proximal surface 922 resists movement of the tab 804
distally of the detent 914. The detent 914 thus locks the piston portion
904 in its extreme distal position relative to the branch portion 924.

[0111] FIGS. 20 and 21 illustrate another alternative embodiment of the
present apparatus for selectively establishing a needleless injection
port on IV tubing. With reference to FIG. 20, the apparatus includes a
branch portion 1000 having guide channels 1002 in its sidewall. The
illustrated embodiment includes two opposed guide channels 1002, but
those of ordinary skill in the art will appreciate that the branch
portion 1000 may include any number of guide channels 1002.

[0112] Each guide channel 1002 includes a proximal portion 1004 that
extends longitudinally, a medial portion 1006 that extends
circumferentially, and a distal portion 1008 that extends longitudinally.
A cantilevered arm 1010, similar in structure and function to the
cantilevered arms 544 described above with respect to FIG. 12, extends
into the distal portion 1008 of the guide channel 1002. A space 1012
distal of the cantilevered arm 1010 traps a tab 1014 on the piston
portion 1016 (FIG. 21), as described in detail below.

[0113] With reference to FIG. 21, the piston portion 1016 includes first
and second tabs 1014. The tabs 1014 extend outwardly from an annularly
shaped intermediate shaft portion 1018 into an annular space 1020. To
mount the piston portion 1016 on the branch portion 1000, the proximal
end 1022 of the branch portion 1000 is positioned within the annular
space 1020 such that the tabs 1014 are aligned with the proximal portions
1004 of the guide channels 1002. A tab 1024 extends into each proximal
portion 1004, narrowing the width of proximal portion 1004 in that
region. To advance the tabs 1014 past the tabs 1024. force must be
applied to squeeze the tabs 1014 through the narrower width in the region
of the tabs 1024. The proximal wall 1026 of the branch portion 1000
flexes outwardly to allow the tabs 1024 to pass, and then snaps back to
secure the tabs 1024 beneath the tabs 1014 and secure the piston portion
1016 on the branch portion 1000.

[0114] To advance the piston portion 1016 distally with respect to the
branch portion 1000, the operator rotates the piston portion 1016 such
that the tabs 1024 advance through the medial portion 1006 toward the
distal portion 1008. A tab 1028 extends into the medial portion 1006 at
the elbow between the medial portion 1006 and the distal portion 1008.
The tab 1028 narrows the width of medial portion 1006 in that region. To
advance the tabs 1014 past the tabs 1028, force must be applied to
squeeze the tabs 1014 through the narrower width in the region of the
tabs 1028. When the tabs 1014 advance past the tabs 1028 and into the
distal portion 1008, the operator applies a distally directed force to
the piston portion 1016. The tabs 1014 advance distally through distal
portion 1008 as the piston portion 1016 advances distally along the
branch portion 1000. The cantilevered arms 1010 trap the tabs 1014 in the
space 1012 in a manner similar to that described above with respect to
FIG. 12.

[0115] The present embodiments advantageously reduce the overall cost of
IV tubing and needleless injection ports by decoupling the manufacturing
processes for tubing and ports. Instead of manufacturing tubing with a
built-in port, the present embodiments enable tubing and ports to be
manufactured separately, and combined as needed by medical personnel.
Fewer ports thus go unused.

[0116] The above description presents the best mode contemplated for
carrying out the present apparatus for selectively establishing a
needleless injection port on IV tubing, and associated methods, and of
the manner and process of making and using it, in such full, clear,
concise, and exact terms as to enable any person skilled in the art to
which it pertains to make and use this apparatus. This apparatus is.
however, susceptible to modifications and alternate constructions from
that discussed above that are fully equivalent. Consequently. this
apparatus is not limited to the particular embodiments disclosed and
certain features disclosed for one embodiment may be incorporated in
another embodiment provided their functions are compatible. On the
contrary, this apparatus covers all modifications and alternate
constructions coming within the spirit and scope of the apparatus as
generally expressed by the following claims, which particularly point out
and distinctly claim the subject matter of the apparatus. Further, the
invention illustratively disclosed herein suitably may be practiced in
the absence of any element, which his not specifically disclosed herein.